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Background <p>Recent studies have demonstrated the superior benefits of clopidogrel compared to aspirin in reducing mortality, myocardial infarction, stroke, and hospitalization in chronic stable patients with coronary stenting. Furthermore, dual pathway inhibition by combining low-dose rivaroxaban with aspirin (DPI) has shown superior effects in preventing cardiovascular death, myocardial infarction, and stroke in stable atherosclerotic patients. However, no studies have directly compared these treatment strategies in the same population. This randomized controlled trial aims to compare clopidogrel-based antiplatelet therapy with or without aspirin (CAPT) to DPI in a 1:1 ratio in patients with high-risk coronary artery disease (CAD) or in patients with both CAD and peripheral artery disease (PAD).</p> Methods <p>Optimal strategy for treatment of <i>A</i>therosclerotic cardiovascular disease—comparison of <i>C</i>lopidogrel-based <i>A</i>ntiplatelet agent treatment versus aspirin plus low dose <i>R</i>ivaroxaban <i>T</i>herapy (OACART) trial is a randomized multi-center study comparing the performance of the maintaining CAPT or DPI in a 1:1 ratio. The trial is powered for the non-inferiority of the CAPT in patients with chronic stable high-risk CAD or CAD+PAD to DPI with respect to the primary and secondary efficacy endpoints at 36&#xa0;months.</p> Results <p>Between November 2023 and April 2026, we will recruit 2758 participants from multi-center in Korea, and we will examine the net clinical outcome, including all-cause death, any myocardial infarction, any stroke, any ischemia-driven revascularization (CAD or PAD), acute limb ischemia, any major or minor amputations, any acute thromboembolism, and International Society on Thrombosis and Haemostasis major bleeding at 36&#xa0;months after study enrollment.</p> Conclusions <p>OACART trial will provide the optimal antithrombotic treatment strategy for patients with stable high-risk atherosclerosis.</p> Trial registration <p>Clinical Research Information Service (CRIS) of Republic of Korea, KCT0008458, registered on May 22, 2023. <a href="https://cris.nih.go.kr/cris/search/detailSearch.do?seq=28968&amp;search_page=L">https://cris.nih.go.kr/cris/search/detailSearch.do?seq=28968&amp;search_page=L</a></p>

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Optimal strategy for treatment of atherosclerotic cardiovascular disease—comparison of clopidogrel-based antiplatelet agent treatment versus aspirin plus low dose rivaroxaban therapy (OACART study): a study protocol for a multicenter, open-label, randomized, non-inferiority trial

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年7月30日

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  • Ju-Seung Kwun,
  • Chang-Hwan Yoon,
  • Ki-Hyun Jeon,
  • Hyoung-won Cho,
  • Jin Joo Park,
  • Si-Hyuck Kang,
  • Wonjae Lee,
  • Jung-Won Suh,
  • Tae-Jin Youn,
  • Hyun-Jae Kang,
  • Pil-ki Min,
  • Cheol Woong Yu,
  • Jae-Hwan Lee,
  • Seung-Woon Rha,
  • Sanghoon Shin,
  • Bong-Ki Lee,
  • Young Jin Youn,
  • Young-Guk Ko,
  • Ji-Yong Jang,
  • Jae-Kwang Lee,
  • Kyoung-Ha Park,
  • Young Jin Choi,
  • Sang-Rok Lee,
  • Sang-Don Park,
  • Deok-Kyu Cho,
  • Yun-Hyeong Cho,
  • Ju Han Kim,
  • Jin-Ok Jeong,
  • Janghyun Cho,
  • Song-Yi Kim,
  • Tae Soo Kang,
  • Seung-Uk Lee,
  • In-Ho Chae

摘要

Background

Recent studies have demonstrated the superior benefits of clopidogrel compared to aspirin in reducing mortality, myocardial infarction, stroke, and hospitalization in chronic stable patients with coronary stenting. Furthermore, dual pathway inhibition by combining low-dose rivaroxaban with aspirin (DPI) has shown superior effects in preventing cardiovascular death, myocardial infarction, and stroke in stable atherosclerotic patients. However, no studies have directly compared these treatment strategies in the same population. This randomized controlled trial aims to compare clopidogrel-based antiplatelet therapy with or without aspirin (CAPT) to DPI in a 1:1 ratio in patients with high-risk coronary artery disease (CAD) or in patients with both CAD and peripheral artery disease (PAD).

Methods

Optimal strategy for treatment of Atherosclerotic cardiovascular disease—comparison of Clopidogrel-based Antiplatelet agent treatment versus aspirin plus low dose Rivaroxaban Therapy (OACART) trial is a randomized multi-center study comparing the performance of the maintaining CAPT or DPI in a 1:1 ratio. The trial is powered for the non-inferiority of the CAPT in patients with chronic stable high-risk CAD or CAD+PAD to DPI with respect to the primary and secondary efficacy endpoints at 36 months.

Results

Between November 2023 and April 2026, we will recruit 2758 participants from multi-center in Korea, and we will examine the net clinical outcome, including all-cause death, any myocardial infarction, any stroke, any ischemia-driven revascularization (CAD or PAD), acute limb ischemia, any major or minor amputations, any acute thromboembolism, and International Society on Thrombosis and Haemostasis major bleeding at 36 months after study enrollment.

Conclusions

OACART trial will provide the optimal antithrombotic treatment strategy for patients with stable high-risk atherosclerosis.

Trial registration

Clinical Research Information Service (CRIS) of Republic of Korea, KCT0008458, registered on May 22, 2023. https://cris.nih.go.kr/cris/search/detailSearch.do?seq=28968&search_page=L